Research Compliance Project Manager

Research Compliance Project Manager

Inspired by faith. Driven by innovation. Powered by humankindness. CommonSpirit Health is building a healthier future for all through its integrated health services. As one of the nation's largest nonprofit Catholic healthcare organizations, CommonSpirit Health delivers more than 20 million patient encounters annually through more than 2,300 clinics, care sites and 138 hospital-based locations, in addition to its home-based services and virtual care offerings.

The Ivy Brain Tumor Center is a non-conventional, non-profit program offering state-of-the-art clinical trials for patients with the most aggressive form of brain cancer. It is home to the largest collection of Phase 0 trials for brain tumors in the world. Our multidisciplinary team of brain tumor specialists and scientists are accelerating drug discovery and precision medicine in neuro-oncology to identify the most promising first-in-class therapies for brain tumor patients.

The Ivy Compliance Project Manager is responsible and accountable for supervising Ivy Center compliance operations across quality management and privacy. This role will drive the implementation of quality and privacy frameworks in alignment with international regulatory requirements, including FDA, ICH, GCP, GDPR, HIPAA, and other applicable data protection laws.

Role Responsibilities :

• Drive implementation of quality management strategy within Clinical Development, with focus on QMS for a Global Phase 3 Registration Study and Early Phase Clinical Trials.
• Develop and maintain a Center of Expertise (CoE) around quality management activities (e.g., deviation, continuous improvement, change control) to ensure ongoing alignment of quality-related goals and strategy.
• Ensure oversight of quality management system by the leadership team including QPPV and Process Excellence & Quality Director.
• Serve as the primary point of contact for global privacy and data protection matters in clinical research.
• Interpret, apply, and monitor compliance with global privacy laws and frameworks (e.g., GDPR, UK GDPR, Swiss FADP, HIPAA, CCPA, APAC privacy laws).
• Oversee implementation of data protection measures, pseudonymization / anonymization standards, and secure data transfer processes across vendors and collaborators.
• Lead Data Protection Impact Assessments (DPIAs) and risk assessments related to clinical trial data.
• Collaborate with Legal / Compliance and external consultants to maintain adherence to global privacy regulations.
• Support regulatory submissions and inspection readiness by ensuring privacy and quality compliance.
• Establish and maintain robust quality systems, including document control, deviations, CAPA, change control, and risk management.
• Oversee the development and implementation of Standard Operating Procedures (SOPs) to ensure consistent adherence to quality and privacy practices.
• Define key quality and privacy compliance metrics and regularly report on the performance of the systems.
• Provide timely updates to senior management on quality and privacy trends, issues, and improvement initiatives.
• Develop and implement training programs for staff on GCP, quality management, and global privacy / data protection requirements.
• Cultivate a culture of quality, compliance, and data stewardship through ongoing education and effective communication.

Job Requirements :

Required Qualifications :

Preferred Qualifications :

Where You'll Work :

Hello humankindness Located conveniently in the heart of Phoenix, Arizona, St. Joseph's Hospital and Medical Center is a 571-bed, not-for-profit hospital that provides a wide range of health, social and support services. Founded in 1895 by the Sisters of Mercy, St. Joseph's was the first hospital in the Phoenix area. More than 125 years later, St. Joseph's remains dedicated to its mission of caring for the poor and underserved. We are extremely proud to be a nationally recognized center for quality quaternary care, medical education and research. St. Joseph's includes the internationally renowned Barrow Neurological Institute, Norton Thoracic Institute, Cancer Center at St. Joseph's, Ivy Brain Tumor Center, and St. Joseph's Level I Trauma Center (which is verified by the American College of Surgeons). The hospital is also a respected center for high-risk obstetrics, neuro-rehabilitation, orthopedics, and other medical services. St. Joseph's is considered a sought-after destination hospital for treating the most complex cases from throughout the world. Every day, approximately 20 percent of the hospital's patients have traveled from outside of Arizona and the United States to seek treatment at St. Joseph's. U.S News & World Report routinely ranks St. Joseph's among the top hospitals in the United States for neurology and neurosurgery. In addition, St. Joseph's boasts the Creighton University School of Medicine at St. Joseph's, and a strategic alliance with Phoenix Children's Hospital. St. Joseph's is consistently named an outstanding place to work and one of Arizona's healthiest employers. Come grow your career with one of Arizona's Most Admired Companies. Look for us on Facebook and follow us on Twitter. For the health of our community ... we are proud to be a tobacco-free campus.

Depending on the position offered, CommonSpirit Health offers a generous benefit package, including but not limited to medical, prescription drug, dental, vision plans, life insurance, paid time off (full-time benefit eligible team members may receive a minimum of 14 paid time off days, including holidays annually), tuition reimbursement, retirement plan benefit(s) including, but not limited to, 401(k), 403(b), and other defined benefits offerings, as may be amended from time to time. For more information, please visit https : / / www.commonspirit.careers / benefits .

Unless directed by a Collective Bargaining Agreement, applications for this position will be considered on a rolling basis. CommonSpirit Health cannot anticipate the date by which a successful candidate may be identified.